Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported September 19, 2012
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Helix Medical LLC recalled BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP… - a low-severity action.
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP… was recalled by Helix Medical LLC in September 19, 2012. Reason: Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.. Check the official notice for the remedy. Verify recall #Z-2336-2012 with the FDA Devices before acting.
The recall
Helix Medical LLC issued this low-severity FDA Devices recall-Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date..
- Low
- severity level
- 2 units
- affected scope
- Class III
- classification
- September 19, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2336-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2336-2012) was formally reported on September 19, 2012, with the manufacturer initiating the action on March 8, 2012. It is classified under Low severity (Class III), with a current status of Terminated. Helix Medical LLC is listed as the recalling firm, operating out of Carpinteria, CA. Federal records list the affected scope as 2 devices.
The documented reason for this recall is: Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date. Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2 devices
Related Recalls
6
3 from same agency
Product description
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.
Reason for recall
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-2336-2012 |
| Date reported | September 19, 2012 |
| Date initiated | March 8, 2012 |
| Recalling firm | Helix Medical LLC |
| Firm location | Carpinteria, CA |
| Affected scope | 2 devices |
| Distribution | Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2336-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
BLOM-SINGER indwelling TEP Occluder, catalog IN2004-TO The Blom-Singer Indwelling (TEP(tracheoesophageal Puncture) Occluder is a non-valved silicone prosthesis designed for placement in and maintenance of the TE (tracheoesophageal) puncture following total laryngectomy. The Blom-Singer Indwelling TEP (tracheoesophageal Puncture) Occluder is indicated for placement in and maintenance of the TE puncture following total laryngectomy when placement, or replacement, of an indwelling prosthesis is performed by a qualified, trained medical professional.. Recalled by Helix Medical LLC. Units affected: 2 devices.
Why was this product recalled? ▼
Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 19, 2012. Severity: Low. Recall number: Z-2336-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) including state of: Ohio and country of United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2336-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 19, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.